In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.
Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.
Robotic-assisted surgery-focused Intuitive Surgical Inc. revealed its second-quarter results late July 21, with worldwide Da Vinci procedures falling about 19% vs. the same period of 2019. Driven by this decline, second quarter 2020 instruments and accessories (I&A) revenue fell by 20% to $461 million, vs. $579 million in the second quarter of 2019.
Medtronic plc said Wednesday it will purchase Medicrea Group, a French manufacturer of patient-specific 3D printed spinal implants, in a step to further strengthen its spine surgery business. The friendly, all-cash offer is priced at €7 (US$7.98) for each Medicrea share, a 22% over its July 14 closing price. The total value of the deal is approximately €200 million (about US$228 million), which includes roughly €50 million in net cash and liabilities plus about €150 million in equity. Medtronic expects to close the deal by the end of the year, pending regulatory nods in France and the U.S.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.
Medtronic plc has won the U.S. FDA’s nod for the first deep brain stimulation (DBS) system that integrates Brainsense, the company’s technology to sense and record brain signals for more personalized treatment. The next-generation Percept PC DBS with Brainsense is approved to treat symptoms associated with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder.
Royalty deals by an investor into a particular pharmaceutical company program are not unheard of. This structure allows the investor to secure a portion of that specific anticipated upside, while enabling the pharma to fully fund R&D for that program without having to sacrifice other priorities to do so.
Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity.
Toronto-based Titan Medical Inc. has inked a development and license agreement with Medtronic plc, of Dublin, to advance the development of single-port robotic-assisted surgical tools. A separate agreement gives Medtronic licensing rights to certain Titan intellectual property. The arrangement aligns with Medtronic’s goal of building its robotic-assisted surgery business and gives Titan’s financials a needed shot in the arm.
Like many other med-tech companies, Medtronic plc, of Dublin, saw COVID-19 affect its financial results for its fourth quarter and fiscal year 2020, as procedures were deferred in the wake of the pandemic. Quarterly worldwide revenue came in at $5.998 billion, representing a decrease of 26% as reported and 25% on an organic basis.
